Coronary Artery DiseasesNCT02257710
BIOFLOW-III UK Satellite Registry Orsiro Stent System
An observational study of Coronary Artery Diseases, run by Biotronik UK Ltd. at 4 sites in United Kingdom.
Trial summary
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Diseases
- What is being tested?
- Orsiro
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Nov 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects from an all-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES).
Who may be able to join
- Symptomatic coronary artery disease
- Subject signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is ≥ 18 years of age
Who cannot join
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint not reached yet
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
Royal Sussex County Hospital
Brighton, East-Sussex, BN2 5BE
David Hildick-Smith, MD, +441273696955 ext. 4049
David Hildick-Smith, MD
- Recruiting
St Peter's Hospital
Chertsey, Surrey, KT16 0PZ
Michael Mahmoudi, MD, +44 1932 872000
Michael Mahmoudi, MD
- Recruiting
University Hospital Southampton
Southampton
Michael Mahmoudi
- Recruiting
Royal Cornwall Hospital
Truro
Trevor Johnston, Dr.
About this study
Official title: BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III United Kingdom Satellite
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
Read the detailed description
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
- Conditions
- Coronary Artery Diseases
- Being tested
- Orsiro
- Keywords
- national, Multicenter, Observational registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of coronary artery disease, Coronary revascularization, Coronary Intervention, STEMI, NSTEMI, Ischemia, Angina, Acute Myocardial Infarction (AMI), Small Vessels, Chronic Total Occlusion
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Ischemia, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrsiroDevice
| Study group | Role | What they receive |
|---|---|---|
| Orsiro | All subjects requiring coronary revascularization with Drug Eluting Stents (DES) Receives: Device: Orsiro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)
Measured: 12 months
Secondary outcomes (6)
TLF
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)
Measured: 6 months
Target Vessel Revascularization (TVR)
Any repeat revascularization of the target vessel.
Measured: 6 and 12 months
Target Lesion Revascularization (TLR)
Defined as any repeat revascularization of the target lesion.
Measured: 6 and 12 months
Stent Thrombosis
Definite, Probable and Possible Stent Thrombosis
Measured: 6 and 12 months
Clinical Device Success
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without use of a device outside the assigned treatment strategy.
Measured: up to seven days
Clinical Procedural success
Successful delivery and deployment of the investigational stent (s) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of a final residual stenosis of less than 50% by visual estimation and without using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event during the hospital stay to a maximum of the first seven days post index procedure.
Measured: up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startNov 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik UK Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Mahmoudi, MD, Principal investigator, St. Peter's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257710
- Sponsor's protocol ID
- G1402
- Status last verified
- Sep 2017
- First submitted
- 2 Oct 2014
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK - SaFety and Performance Registry for an All-comers Patient Population With the Limus Eluting Orsiro Stent System Within Daily Clinical Practice - III United Kingdom Satellite
- ClinicalTrials.gov ID
- NCT02257710
- Acronym / sponsor ID
- G1402
- Conditions
- Coronary Artery Diseases
- Keywords
- national, Multicenter, Observational registry, Orsiro Drug Eluting Stent (DES), Stenting, Treatment of coronary artery disease, Coronary revascularization, Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Biotronik UK Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
Detailed description
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.
The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.
Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orsiro | – | Device: OrsiroAll subjects requiring coronary revascularization with Drug Eluting Stents (DES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects from an all-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES).
Key inclusion criteria (4 listed)
- Symptomatic coronary artery disease
- Subject signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow up assessments
- Subject is ≥ 18 years of age
Key exclusion criteria (5 listed)
- Subject did not sign informed consent for data release
- Pregnancy
- Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
- Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint not reached yet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orsiro | Device | Orsiro |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
Composite of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) and clinically driven Target Lesion Revascularization (TLR)
6 secondary outcomes
TLF
Time frame: 6 months
Target Vessel Revascularization (TVR)
Time frame: 6 and 12 months
Target Lesion Revascularization (TLR)
Time frame: 6 and 12 months
Stent Thrombosis
Time frame: 6 and 12 months
Clinical Device Success
Time frame: up to seven days
Clinical Procedural success
Time frame: up to seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mahmoudi, MD principal investigator
St. Peter's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Diseases, run by Biotronik UK Ltd. at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Knott (+44 (0) 7970084632, marcus.knott@biotronik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.